Diplomatic scandal: Sputnik V to take legal action against Brazilian regulator who did not authorize coronavirus vaccine

Russian developers of the Sputnik V covid-19 vaccine announced Thursday that they will file a libel action against Brazilian regulator Anvisa, that he refused to authorize the importation of the drug, accusing him of knowingly spreading false information without testing his product.

“Following the admission of the Brazilian regulator Anvisa that he had not tested the Sputnik V vaccine, Sputnik V initiates libel lawsuits in Brazil against Anvisa for knowingly disseminating false and inaccurate information “, the manufacturer said on the official Sputnik V Twitter account. “Anvisa made incorrect and misleading claims without testing the real Sputnik V vaccine.”

The board of the Brazilian National Agency for Health Surveillance on Monday rejected the importation of Sputnik V, a vaccine approved in more than 60 countries, after technical staff warned of flaws in its development as well as incomplete data on the safety and efficacy of the vaccine.

A crucial issue for the Brazilian regulator was the risk of other viruses used – to make the vaccine work – reproducing in patients, which an expert from Anvisa described as a “serious” defect.

Sputnik V’s official Twitter account shared a note from a Brazilian media outlet citing the same expert, saying that no tests had been carried out to prove the Brazilian theory.

The lawsuit turns the dispute into a diplomatic affair between Brazil and Russia. On Wednesday, the creators of Sputnik V estimated that the Brazilian decision had a “political character” and it has nothing to do with the Russian vaccine “or the science”.

“The quality and safety of Sputnik V are guaranteed, among other things, by the fact that, unlike other vaccines, it uses a four-stage scrubbing technology which includes two chromatographic purification steps and two tangential flow filtration steps, ”noted the Russian researchers.

This technique, they added, “allows to obtain a highly purified product which is also subjected to a cmandatory ontrol which includes testing for the presence of (replicating adenovirus) RCA or any additives “, something the Brazilian side suggested earlier.

For his part, the president of Anvisa, Antonio Barra Torres placeholder image, indicated that the Russian manufacturer had not submitted the “full technical report” of the immunizer and that a technical visit to the facilities of the Gamaleya Institute had also been prevented.

In Brazil, which has vaccinated 29 million people with at least the first dose, the vaccine is being administered urgently Coronavac, from the Chinese laboratory Sinovac, and with final registration for its use on Covishield.

Definitive use of the vaccine is also approved in Brazil Tozinameran, while the Belgian laboratory vaccine Janssen it is also approved for emergency use.

The day before the Kremlin assured that Russia was prepared to provide Brazil with the information necessary for that country’s health regulator to authorize the supply. and the use of Sputnik V.

The doubts of scientists

Several international scientists have backed the Brazilian drug regulator’s decision and called for more research to ensure the safety of the Russian vaccine.

The prestigious Canadian virologist Angela Rasmussen He stressed this Thursday to various media and on his Twitter profile that the Brazilian finding “Raises questions about the integrity of manufacturing processes“And it could be a safety concern for people with weaker immune systems, if it is concluded that the problem is generalized.

Rasmussen, researcher at Canadian Organization for Infectious Diseases and Vaccines, described the problem as a matter of quality control, rather than as an inherent component of vaccine technology. Is the technology used by the Instituto Gamaleya who developed the Russian vaccine is the same one developed by other laboratories such as Johnson & johnson Yes AstraZeneca.

For his part, the renowned Italian virologist Roberto Burioni, from San Raffaele Hospital in Milan, noted: “The Sputnik problem appears to be serious. The vaccine must consist of a virus that cannot replicate, while all samples analyzed in Brazil contained viruses capable of replicating. Unanimous rejection is not surprising“.

“Vector replication means that Russia has failed to control the quality of the vaccine, but that does not mean that Sputnik V is bad or that people who receive it can get seriously ill.“Explained the scientist Oscar Bruna-Romero, professor of infectious diseases and vaccines at the Department of microbiology of Federal University of Santa Catarina.

Denis logunov, Deputy Director of Instituto Gamaleya, replied by saying that “statements in the press have nothing to do with reality“, And that the vector adenovirus failed to replicate.

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